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Application of 3D-printed bolus in adjuvant radiotherapy after radical mastectomy for breast cancer

The Application value of 3D-printed bolus in adjuvant radiotherapy after radical mastectomy for breast cancer and dosimetric comparison with conventional bolus

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090642
Enrollment
Unknown
Registered
2024-10-10
Start date
2024-09-25
Completion date
Unknown
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

3D-printed bolus group:Using 3D printing for bolus
Control group:Using conventional bolus

Sponsors

Binzhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients who need to receive high dose of skin irradiation after radical mastectomy; 2. The patient should be conscious and able to cooperate with positioning and treatment. 3. The Karnofsky Performance Status (KPS) score should be =70. 4. The age range should be between 18 and 70 years, and the patient should not be pregnant or breastfeeding. 5. The patient should be willing to participate in the study, undergo necessary examinations and follow-up, and provide written informed consent as mentioned above.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously received radiation therapy to the chest. 2. Patients who have previously undergone surgeries other than radical mastectomy of the breast. 3. Patients with urgent medical conditions or rapidly growing lesions, where significant changes in surface contour may occur within the production period of personalized 3D-printed bolus. 4. Patients with significant pain in the intended radiation treatment area who cannot tolerate compression from the bolus. 5. Patients with severe mental illness or psychological disorders, central nervous system disorders, cardiovascular complications, epilepsy, or other conditions that prevent them from providing written informed consent and have poor treatment compliance. 6. Patients with severe and uncontrollable infectious diseases.

Design outcomes

Primary

MeasureTime frame
Skin toxicity reaction;Skin dose;Comfort satisfaction survey;

Secondary

MeasureTime frame
homogeneity index;

Countries

China

Contacts

Public ContactLiu Huiling

Binzhou People's Hospital

juzidoctor@163.com+86 183 0649 1291

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026